Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114881
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2005-06-17
Brief Title:
Urban Environmental Factors and Childhood Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Urban Environment and Childhood Asthma URECA
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
URECA
Brief Summary:
Minority children who grow up in poor urban neighborhoods have the highest rates of asthma and also experience greater morbidity from acute exacerbations of this disease The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of wheezing atopy and asthma for purposes of identifying new strategies for asthma prevention
Detailed Description:
The purpose of this study is to determine the way environmental factors like the components of inner-city household dust affect immune system development and symptoms of asthma in inner city children The study is divided into five periods as the subjects age from birth to 17 years old Each age bracket will explore different objectives and endpoints
Study ObjectivesHypotheses
1 Subjects age 0 to 3 years old
Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation allergy and recurrent wheezing by age 3
Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6
2 Subjects age 4 to 7 years old
There is a unique pattern of immune development that is driven by specific urban exposures in early life and this pattern of immune development is characterized by 1 impairment of antiviral responses and 2 accentuation of Th2-like responses eg cockroach-specific Interleukin-13IL-13 The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age and these characteristics synergistically increase the risk of asthma at age 7 years
3 Subjects age 7 to 10 years old
There are unique combinations of environmental exposures cockroach allergens indoor pollutants Environmental Tobacco Smoke ETS and Nitrogen Dioxide NO2 lack of microbial exposure and family characteristics stress genetic factors related to innate immunity that synergistically promote asthma onset persistence and morbidity in urban neighborhoods These exposures and characteristics influence immune expression and lung development during critical periods of growth resulting in specific asthma phenotypes
4 Subjects age 10 to 16 years old
-To determine the wheezing asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence
5 Subjects to age 17 Continuation of phase 4 to follow participants to age 17 To determine the wheezing asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence
Study ObjectivesHypotheses
1 Subjects age 0 to 3 years old
Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation allergy and recurrent wheezing by age 3
Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6
2 Subjects age 4 to 7 years old
There is a unique pattern of immune development that is driven by specific urban exposures in early life and this pattern of immune development is characterized by 1 impairment of antiviral responses and 2 accentuation of Th2-like responses eg cockroach-specific Interleukin-13IL-13 The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age and these characteristics synergistically increase the risk of asthma at age 7 years
3 Subjects age 7 to 10 years old
There are unique combinations of environmental exposures cockroach allergens indoor pollutants Environmental Tobacco Smoke ETS and Nitrogen Dioxide NO2 lack of microbial exposure and family characteristics stress genetic factors related to innate immunity that synergistically promote asthma onset persistence and morbidity in urban neighborhoods These exposures and characteristics influence immune expression and lung development during critical periods of growth resulting in specific asthma phenotypes
4 Subjects age 10 to 16 years old
-To determine the wheezing asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence
5 Subjects to age 17 Continuation of phase 4 to follow participants to age 17 To determine the wheezing asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID CRMS ID 20126 | OTHER | DAIT NIAID | None |